Abbott Receives U.S. FDA Approval for AndroGel 1.62% to Treat Men with Low Testosterone

Abbott ABT announced today that the U.S. Food and Drug Administration has approved AndroGel 1.62%, a clear, odorless, gel formulation shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared to AndroGel 1%. At the starting dose, the new AndroGel 1.62% contains 40.5 mg of testosterone in two pump presses, whereas AndroGel 1% contains 50 mg of testosterone in four pump presses. Dosage and administration for AndroGel 1.62% differs from AndroGel 1% and the two are not interchangeable. Both AndroGel 1.62% and AndroGel 1% are prescription medications used to treat adult males with low or no testosterone, also known as hypogonadism.